P001 What is the role of antidrug antibody and drug level testing in patients treated with infliximab and adalimumab?

Abstract Background/Aims Approximately 30-40% of rheumatology patients fail to respond to first-line biologics. Secondary inefficacy is mediated by immune complex formation between biologic agents and anti-drug antibodies. Anti-drug antibody testing has been undertaken at Sheffield Teaching Hospitals since October 2015. However, there are currently no national guidelines or consensus on what levels of anti-drug antibodies are clinically significant or what changes to therapy are suggested as a consequence of these tests. We aimed to review the reasons for and outcomes of anti-drug antibody levels tested at STH in patients on Adalimumab or Infliximab. Methods Retrospective review of records of all Rheumatology patients having antidrug antibody levels tested October 2015 - April 2019. Results 237 patients were included in this analysis. The mean age of patients was 48 years. 43% were male. The most common reasons for testing antibody levels were clinical evidence of a flare in disease (n = 92) and patient reported worsening of symptoms (n = 88). 66% (n = 157) of antibody levels tested were negative, 21% (n = 49) of tests were strongly positive (antibody titre >50). Serum drug concentrations were subtherapeutic in 20 % (n = 47), therapeutic in 22% (n = 51) and supratherapeutic in 38% (n = 91). In 51% of patients (n = 119) the current treatment regime was continued. However, 38% (n = 90) changed biologics, and dosing schedule was changed in 2% (n = 6). Antibody titres were more likely to be strongly positive in patients who had clinically active disease compared to those who had symptoms but no clinical evidence of disease (30% vs 10% p = 0.009). Those with strongly positive antibodies were more likely to switch biologics than those with normal antibodies (84% vs 28%, p = 0.01). Patients with clinically active disease but normal antibodies and drug levels were more likely to switch biologics than patients with no evidence of active disease but positive antibodies (p = 0.03). Underlying diagnosis (p = 0.23) or concomitant DMARD use (p = 0.92) were not associated with positive autoantibodies. Of the 47 patients with subtherapeutic drug levels, 61% (n = 29) had strongly positive anti-drug antibodies and 73% (n = 34) subsequently switched biologics. 49% (n = 111) of patients had both therapeutic drug levels and normal antibodies. Of these, 22% (n = 25) switched biologics. Of the 25 patients that switched biologics 24% (n = 6) did not have evidence of active disease and 76% (n = 19) had active disease. Conclusion 33% of patients had positive autoantibodies. 39% of patients switched biologics following testing. There was no protective effect of DMARDs identified. Patients with active disease were more likely to have positive antibodies and to switch biologics than those with no clinical evidence of disease. 25% of patients had subtherapeutic drug levels. However, only 2% of patients had a dose schedule adjustment. Therefore, dosing schedule alterations could be considered in these patients prior to escalating to a more expensive biologic. Disclosure M. Cox: None. R. Smith: None. G. Wild: None. L. Dunkley: None.

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P01 An evaluation of vancomycin therapy in paediatric patients post guideline change

Archives of Disease in Childhood ◽

10.1136/archdischild-2020-nppg.10 ◽

2020 ◽

Vol 105 (9) ◽

pp. e6.1-e6 ◽

Cited By ~ 1

Author(s):

Adedoyin Agbonin ◽

Joanne Crook

Keyword(s):

Adverse Effects ◽

Renal Impairment ◽

Therapeutic Drug ◽

Drug Levels ◽

Paediatric Patients ◽

Patient Reported ◽

The Right ◽

Higher Doses ◽

Trough Levels ◽

Local Guideline

AimTo evaluate the prescribed dose of vancomycin as per local guideline and review the achieved therapeutic drug levels.MethodRetrospective data was collected from paediatric inpatients that were prescribed vancomycin for more than 24 hours during the audit period. Data was obtained from the Trust’s electronic prescribing system, LastWord. Measured standards included initial vancomycin dose, dose prescribed for renal impairment, time to first trough level and any required dose adjustments as per local guidance. The dose bands for each age group were1; birth - 6 months 15 mg/g 8 hourly; >6 months -12 months 20 mg/kg 8 hourly; >12 months – 12 years 25 mg/kg 8 hourly; >12 years 20 mg/kg 8 hourly. The number of patients achieving therapeutic vancomycin trough levels was recorded. Safety data was collected, including reported adverse effects, infusion related reactions and renal impairment. Renal impairment was defined as an increase in creatinine by 50%. Data was collected from April 2018 for 6 months. Relevant data with regards to patient demographics, dosing and drug levels were collected and analysed using Microsoft Excel.Results12 patients received 15 doses of vancomycin over 6 months. 67% of initial vancomycin doses were prescribed as per local guideline, 60% of therapeutic trough levels were taken at the right time and 71% of patients that were prescribed the correct dose and had levels taken at the right time achieved therapeutic trough levels. 12 patients required dose adjustments. One patient with renal impairment was not prescribed the recommended dose as per local guidance. One patient reported an infusion related reaction, which was overcome by increasing the infusion time. Two patients who received therapy for >7 days accumulated vancomycin and recorded high trough levels, with no adverse events. One patient reported an increase in creatinine by 50% over the treatment period.ConclusionsVancomycin has the potential to induce nephrotoxicity and ototoxicity when consistently at high serum drug levels. Due to its narrow therapeutic index, drug levels should be monitored to ensure the drug does not accumulate. The licensed dose and dose listed in the BNF for Children 2 3 has historically under dosed patients at our trust, leading to the risk of ineffective therapy and bacterial resistance. It is unclear from research what the optimal dose is for paediatric patients.More research is needed to determine the correct paediatric dose of vancomycin. Higher doses than currently recommended as per licence resulted in three quarters of patients achieving therapeutic levels, however 12 patients still required dose adjustment. No patients suffered irreversible adverse effects or toxicity, suggesting that higher doses are safe to use in the paediatric population. Further education is required for those involved in the prescribing, administering and monitoring of Vancomycin in paediatric patients to ensure its safe use. Additional monitoring is required for those receiving higher doses >7 days to prevent drug accumulation, alternatively a loading dose followed by lower maintenance dose may be a more suitable dosing regimen.ReferencesHughes S, Crook J, Ross J. Vancomycin intravenous dosing guideline - paediatrics. Chelsea and Westminster Hospital; 2017.Stockman C, Sammons H, Stakey E, et al. Unanswered Questions Regarding Optimal Pediatric Vancomycin Use. Therapeutic Drug Monitoring 2016; 38:491–420.National Institute for Health and Care Excellence. Vancomycin. Available from https://bnfc.nice.org.uk/drug/vancomycin.html [Accessed 10th Oct 2018]

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Infliximab concentrations in two non-switching cohorts of patients with inflammatory bowel disease: originator vs. biosimilar

Scientific Reports ◽

10.1038/s41598-020-74235-1 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Ana Martínez-Feito ◽

Luz Yadira Bravo-Gallego ◽

Borja Hernández-Breijo ◽

Jesús Diez ◽

Laura García-Ramirez ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Clinical Outcomes ◽

Bowel Disease ◽

Infliximab Treatment ◽

Drug Levels ◽

Antidrug Antibody ◽

Inflammatory Bowel ◽

Post Hoc ◽

Antibody Levels ◽

Trough Levels

Abstract Biosimilars are replacing originator compounds due to their similar effectiveness, safety and pharmacokinetics. Our objective was to compare the differences in pharmacokinetics and clinical outcomes between the originator infliximab (Ifx) and the biosimilar CT-P13 in a patient cohort with inflammatory bowel disease (IBD). Our cohort study included 86 patients from a historical and a prospective cohort from the start of infliximab treatment to 22 weeks later. Serum infliximab, antidrug antibody levels and other serum biomarkers were measured at weeks 0, 2, 6, 14 and 22. Remission outcomes were evaluated at weeks 14 and 22. Drug levels were measured prospectively and analysed using MANOVA. Of the 86 patients, 44 (51%) and 42 (49%) were administered the originator and CT-P13, respectively. Originator trough levels were higher than the biosimilar trough levels (35 vs. 21, 20.1 vs. 11, 6.6 vs. 2.9 and 4.3 vs. 1.7 μg/mL at weeks 2, 6, 14 and 22, respectively). A post-hoc analysis demonstrated changes in mean serum drug levels over time (p < 0.001) and according to the drug employed (p = 0.001). At week 22, 13 (81%) patients administered the originator achieved clinical remission compared with 5 (19%) patients with the biosimilar (p = 0.02). None of the patients administered the originator withdrew from the treatment compared with 7 for the biosimilar. During the study, there were significant differences in serum infliximab levels between the originator and the CT-P13 in the patients with IBD. The clinical outcomes were influenced by the type of compound administered.

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Therapeutic Drug Monitoring of Piperacillin-Tazobactam Using Spent Dialysate Effluent in Patients Receiving Continuous Venovenous Hemodialysis

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00548-10 ◽

2010 ◽

Vol 55 (2) ◽

pp. 557-560 ◽

Cited By ~ 25

Author(s):

Michael J. Connor ◽

Charbel Salem ◽

Seth R. Bauer ◽

Christina L. Hofmann ◽

Joseph Groszek ◽

...

Keyword(s):

Therapeutic Drug Monitoring ◽

Drug Monitoring ◽

Kidney Injury ◽

Therapeutic Drug ◽

Plasma Drug ◽

Drug Dosing ◽

Drug Levels ◽

Drug Concentrations ◽

Continuous Venovenous Hemodialysis ◽

Dosing Strategies

ABSTRACTSepsis and multisystem organ failure are common diagnoses affecting nearly three-quarters of a million Americans annually. Infection is the leading cause of death in acute kidney injury, and the majority of critically ill patients who receive continuous dialysis also receive antibiotics. Dialysis equipment and prescriptions have gradually changed over time, raising concern that current drug dosing recommendations in the literature may result in underdosing of antibiotics. Our research group directed its attention toward antibiotic dosing strategies in patients with acute renal failure (ARF), and we sought data confirming that patients receiving continuous dialysis and antibiotics actually were achieving therapeutic plasma drug levels during treatment. In the course of those investigations, we explored “fast-track” strategies to estimate plasma drug concentrations. As most antimicrobial antibiotics are small molecules and should pass freely through modern high-flux hemodialyzer filters, we hypothesized that continuous renal replacement therapy (CRRT) effluent could be used as the medium for drug concentration measurement by reverse-phase high-pressure liquid chromatography (HPLC). Here we present the first data demonstrating this approach for piperacillin-tazobactam. Paired blood and dialysate trough-peak-trough samples were drawn from 19 patients receiving piperacillin-tazobactam and continuous venovenous hemodialysis (CVVHD). Total, free, and dialysate drug concentrations were measured by HPLC. Dialysate drug levels predicted plasma free drug levels well (r2= 0.91 and 0.92 for piperacillin and tazobactam, respectively) in all patients. These data suggest a strategy for therapeutic drug monitoring that minimizes blood loss from phlebotomy and simplifies analytic procedures.

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Therapeutic Drug Monitoring in the Treatment of Active Tuberculosis

Canadian Respiratory Journal ◽

10.1155/2011/307150 ◽

2011 ◽

Vol 18 (4) ◽

pp. 225-229 ◽

Cited By ~ 38

Author(s):

Aylin Babalik ◽

Sharyn Mannix ◽

Denis Francis ◽

Dick Menzies

Keyword(s):

Therapeutic Drug Monitoring ◽

Drug Monitoring ◽

Therapeutic Benefit ◽

Active Tuberculosis ◽

Therapeutic Drug ◽

Smear Microscopy ◽

Retrospective Case ◽

Drug Levels ◽

Drug Concentrations ◽

Culture Conversion

Therapeutic drug monitoring ensures optimal dosing while aiming to reduce toxicity. However, due to the high costs and complexity of testing, therapeutic drug monitoring is not routinely used in the treatment of individuals with active tuberculosis, despite the efficacy demonstrated in several randomized trials. This study reviewed data spanning five years regarding the frequency of finding low drug levels in patients with tuberculosis, the dosing adjustments that were required to achieve adequate levels and the factors associated with low drug levels.BACKGROUND: Therapeutic drug monitoring (TDM) is used to optimize dosing that maximizes therapeutic benefit while minimizing toxicity. In the treatment of active tuberculosis (TB), TDM is not routine, yet low levels of anti-TB drugs can be associated with poorer treatment outcomes.METHODS: In a retrospective case control study, patients with active TB in whom TDM was performed were considered cases and compared with controls who did not undergo TDM, and matched according to year of diagnosis and the results of direct smear microscopy. Medical records were reviewed to abstract demographic, clinical, radiographic and microbiological data including time until smear and culture conversion.RESULTS: In total, 20 patients were identified in whom TDM was performed, of whom 17 (87%) had at least one low drug concentration. Overall, 27 of 45 (60%) initial drug concentrations were low and resulted in an increased drug dosage. Low drug levels were found in 13 of 15 (87%) isoniazid, four of five (80%) rifabutin and eight of 12 (67%) rifampin measurements, but in only two of 13 (15%) pyrazinamide measurements. Within cases only, the 17 patients with low serum drug levels were significantly more likely to have comorbid illnesses, be smear positive, have lower serum albumin levels and had nonsignificantly longer time to culture conversion, compared with the three cases in whom all drug levels were within therapeutic ranges.CONCLUSIONS: TB drug levels were frequently below clinically acceptable levels in patients with active TB, particularly in those with HIV infection or other comorbidities. TDM is potentially useful for the treatment of active TB, but is currently underused.

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Evaluation of Therapeutic Drug Monitoring in a Long-Term Care Facility: A Pilot Project

Drug Intelligence & Clinical Pharmacy ◽

10.1177/106002808802200717 ◽

1988 ◽

Vol 22 (7-8) ◽

pp. 594-596 ◽

Cited By ~ 2

Author(s):

Frank Pucino ◽

Peggy J. Baumgart ◽

Gordon L. Strommen ◽

Inger-Lise Silbergleit ◽

Dave Forbes ◽

...

Keyword(s):

Therapeutic Drug Monitoring ◽

Drug Monitoring ◽

Long Term Care ◽

Care Facility ◽

Therapeutic Drug ◽

Term Care ◽

Drug Levels ◽

Long Term Care Facility ◽

Drug Concentrations

The need for a therapeutic drug monitoring service was evaluated in a 150-bed long-term care facility. Thirty blood samples from 28 residents (mean age 87.9 years) were assayed to determine trough drug concentrations. All subjects were examined to determine pharmacodynamic effect. Pharmacokinetic consultations were written for serum drug concentrations outside accepted ranges. Fifty percent (15 of 30) of serum drug levels measured were subtherapeutic; the remaining levels were in the normal therapeutic range. Based on this sample data, it could be concluded that a minimum of 32 percent and as many as 68 percent of serum drug levels would be subtherapeutic following drug analysis in similar nursing home populations. Of 12 consultations, recommendations for seven (58 percent) were accepted by the subject's primary care physicians. Four of the consultations (33 percent) resulted in dosage modifications. These results support the need for further study.

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Clinical Applicability of Monitoring Antihypertensive Drug Levels in Blood

Hypertension ◽

10.1161/hypertensionaha.120.15038 ◽

2020 ◽

Vol 76 (1) ◽

pp. 80-86 ◽

Cited By ~ 3

Author(s):

Laura E.J. Peeters ◽

Lida Feyz ◽

Eric Boersma ◽

Joost Daemen ◽

Teun van Gelder ◽

...

Keyword(s):

Antihypertensive Drugs ◽

Limit Of Detection ◽

Plasma Concentrations ◽

False Negative ◽

Therapeutic Drug ◽

Model Parameters ◽

Time Interval ◽

Drug Levels ◽

Clinical Applicability ◽

Drug Concentrations

Dried blood spot (DBS) analysis is a novel analytical method for therapeutic drug monitoring to identify nonadherence to antihypertensive drugs. This study was conducted to evaluate the clinical applicability of measuring drug concentrations of 8 antihypertensive drugs, using DBS and venipuncture. Furthermore, this study aimed to provide more insight into the between-patient variability in drug concentrations. False-negative values from DBS compared with a venipuncture were determined to assess drug adherence. A generalized estimating equation was used to estimate the model parameters, including sex, dose, age, weight, and the time interval, between drug intake and sampling, on the C plasma (drug concentration in plasma). No false-negative values were found when measuring nonadherence using DBS compared with venipuncture. A high variability in C plasma between patients was observed, especially at peak concentrations with a fold change reaching from 2.3 to 35.2. The time of intake was significantly related to the height of the C plasma in 7 of the 8 measured drugs with a P <0.05, but the influence of dose, weight, age, and sex on drug levels differed largely between the measured drugs. DBS is a reliable and convenient method to assess nonadherence to antihypertensive drugs in clinical practice. The C plasma of the 8 antihypertensive drugs in this study show a large interindividual difference, and therefore, low plasma concentrations do not necessarily mean nonadherence. Nonadherence can only be confirmed if drug levels are undetectable, that is, values below the lower limit of detection.

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DOP62 Immunogenicity to second anti-TNF therapy (IMSAT): Implications for sequencing of biologic therapy

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab073.101 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S097-S098

Author(s):

N Chanchlani ◽

S Lin ◽

A Thomas ◽

B Hamilton ◽

R Nice ◽

...

Keyword(s):

Treatment Failure ◽

Retrospective Cohort ◽

Biologic Therapy ◽

Case Note ◽

Therapeutic Drug ◽

Antibody Concentration ◽

Drug Levels ◽

Loss Of Response ◽

Antibody Levels ◽

Case Note Review

Abstract Background Anti-TNF (aTNF) treatment failure in patients with IBD is common. International guidelines recommend switching out of class when aTNF drug levels are therapeutic and within class with an immunomodulator when aTNF drug levels are suboptimal and associated with antibody development. We sought to define the: 1) risk of immunogenicity to a second aTNF stratified by immunogenicity to the first aTNF and 2) rates of drug persistence to a second aTNF in patients with pharmacodynamic or immunogenic failure of their first aTNF drug. Methods We performed a retrospective cohort study across 32 UK hospitals. 870 patients (444 male, 630 (72%) Crohn’s disease) who had both infliximab and adalimumab therapeutic drug monitoring performed by our service from May 2013 to November 2020 were identified. Drug and antibody levels were measured using the IDKmonitor® drug tolerant ELISA assays. Treatment failure included primary nonresponse, secondary loss of response, adverse drug reactions and IBD-related surgeries, and was identified by case note review. Immunogenic failure was defined as treatment failure with suboptimal drug levels (infliximab level <2 mg/L, adalimumab level <6 mg/L) with an antibody concentration ≥10 AU/ml. Pharmacodynamic failure was defined as treatment failure despite adequate drug levels. Results Patients who developed immunogenicity to adalimumab (first) were more likely to develop immunogenicity to infliximab (second) (63% vs 40%, p = 0.004), and patients who developed immunogenicity to infliximab (first) were more likely to develop immunogenicity to adalimumab (second) (33% vs 19%, p = 0.002) (Fig 1). Patients who developed: antibodies and undetectable drug, low drug levels, or low drug levels with immunogenicity to infliximab (first), were more likely to develop these outcomes to adalimumab (second) (all p<0.001). There was no difference in drug persistence to second aTNF in patients with pharmacodynamic and immunogenic treatment failure (Fig 2). In patients with immunogenic (but not pharmacodynamic) failure, commencing an immunomodulator at the time of switching to second aTNF drug was associated with longer drug persistence than in patients treated with an immunomodulator throughout or not all (Fig 3). Conclusion Immunogenicity to the first aTNF was associated with immunogenicity to the second aTNF, irrespective of drug sequence. Commencing an immunomodulator at the time of switching to second aTNF was associated with improved drug persistence in immunogenic, but not pharmacodynamic, failure. However, 50% of patients remained on second aTNF at 5 years in both groups, suggesting switching in-class may be appropriate irrespective of the cause of treatment failure to first aTNF.

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Therapeutic Drug Monitoring to Guide Clinical Decision Making in Inflammatory Bowel Disease Patients with Loss of Response to Anti-TNF: A Delphi Technique-Based Consensus

Digestion ◽

10.1159/000501930 ◽

2019 ◽

Vol 101 (6) ◽

pp. 683-691 ◽

Cited By ~ 3

Author(s):

Thomas Greuter ◽

Michel H. Maillard ◽

Pascal Juillerat ◽

Pierre Michetti ◽

Frank Seibold ◽

...

Keyword(s):

Decision Making ◽

Inflammatory Bowel Disease ◽

Therapeutic Drug Monitoring ◽

Therapeutic Drug ◽

Drug Levels ◽

Loss Of Response ◽

Antidrug Antibody ◽

Antibody Titers ◽

Inflammatory Bowel ◽

Trough Levels

Background: Loss of response is frequently encountered in patients with inflammatory bowel disease (IBD) treated with antitumor necrosis factor (TNF) agents. Therapeutic drug monitoring (TDM) and antidrug antibody measurement are increasingly used in this setting. Methods: To establish a consensus on the use of TDM in the context of loss of response to anti-TNFs, we performed a vote using a Delphi-style process followed by an expert panel discussion among 8 IBD specialists practicing in Switzerland, Europe. Statements were rated on an even Likert-scale ranging from 1 (strong disagreement) to 4 (strong agreement), based on expert opinion and the available literature. Results: The experts agreed on the following statements: (i) loss of response is associated with inadequate drug levels in both Crohn’s disease and ulcerative colitis; (ii) best timepoint for measuring drug levels is prior to the next application (= trough levels) with different thresholds for anti-TNF agents (infliximab 5 μg/mL, adalimumab 8 μg/mL, certolizumab pegol 10 μg/mL); (iii) antidrug antibodies are predictive for loss of response; and (iv) antidrug-antibody titers and drug trough levels are key determinants in the treatment algorithm. Data about non-anti-TNF biologics were considered too limited to propose recommendations. Conclusion: A Delphi-style consensus among 8 IBD experts shows that TDM and measurement of antidrug-antibody titers are useful in the context of loss of response to anti-TNF. Optimal cutoff levels depend on the type of anti-TNF. These values are critical in the decision making process. More studies are needed to address the value of such measurements for non-anti-TNF biologics.

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P590 Outcomes of patients treated with sequential anti-TNF therapy in a tertiary referral centre

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.718 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S493-S493

Author(s):

C Rowan ◽

J O’Donnell ◽

N Cullen ◽

A O’Toole ◽

K Boland

Keyword(s):

Combination Therapy ◽

Clinical Remission ◽

Antibody Formation ◽

Therapeutic Drug ◽

Referral Centre ◽

Tertiary Referral ◽

Tertiary Referral Centre ◽

Drug Levels ◽

Drug Concentrations ◽

Significant Difference

Abstract Background Anti-TNF agents are administered intravenously(iv) or subcutaneously(SC).Factors such as speed of onset and patient preference influence that decision. The aim of this study was to assess the characteristics and outcomes of patients transitioned between iv and sc anti-TNF therapy. Methods Patients attending a single tertiary referral centre, treated with two different anti-TNF drugs were included. Patient and disease characteristics, biochemical, endoscopic and radiological data were collated. Results 69 patients were included. Table 1 describes the patient cohort. 28 (40.6%) patients transitioned from SC anti-TNF to infliximab (IFX). N=35 (50.7%) switched from IFX to Adalimumab and 6 to Golimumab. 31 patients demonstrated some degree of endoscopic activity prior to anti-TNF switch;14/16 (87.5%) demonstrated radiological activity. 48 patients had endoscopic assessment post-switch; 28 (58.3%) had endoscopic remission.Of the 19 patients with post-transition imaging, 42.1% (8/19) had no active disease. 43 (79.6%) patients had therapeutic trough concentrations of the current anti-TNF. 13 (26%) were previously on combination therapy, while 22 (32.8%) currently are. 24 (39.3%) patients had detectable anti-drug antibodies to their prior anti-TNF, 10 (16.4%) had primary non-response and 12 (19.7%) had loss of response with adequate drug levels. There were significantly more patients with antibody formation in the group switching from IFX to SC anti-TNF (n = 20; p = 0.001). A significantly higher proportion of patients who were transitioned from IFX to SC anti-TNF currently have therapeutic/supratherapeutic drug levels when compared with patients transitioning SC to IFX (p = 0.01). There is no significant difference in the proportion currently on combination therapy (p = 0.668). There is a significant improvement in c-reactive protein, albumin and haemoglobin in the cohort as a whole. However, there is no significant difference in rates of clinical remission (p = 0.556) or endoscopic remission (p = 0.89) after switching from one mode of delivery to another. Conclusion Patients converted from IFX to SC anti-TNF have similar rates of endoscopic and clinical remission to those transitioned to IFX. However, many patients had previous antibody formation. Subsequently, this group has significantly higher rates of therapeutic or supra-therapeutic drug concentrations, suggesting the conscientious use of therapeutic drug monitoring to optimise response.

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Outcomes after kidney transplantation, let’s focus on the patients’ perspectives

Clinical Kidney Journal ◽

10.1093/ckj/sfab008 ◽

2021 ◽

Author(s):

Yiman Wang ◽

Jaapjan D Snoep ◽

Marc H Hemmelder ◽

Koen E A van der Bogt ◽

Willem Jan W Bos ◽

...

Keyword(s):

Kidney Transplantation ◽

Clinical Care ◽

Graft Function ◽

Symptom Burden ◽

Therapeutic Drug ◽

Healthcare Outcomes ◽

Kidney Transplant Recipients ◽

Drug Concentrations ◽

Patient Reported ◽

Related Quality

Abstract Graft function and patient survival are traditionally the most used parameters to assess the objective benefits of kidney transplantation. Monitoring graft function, along with therapeutic drug concentrations and transplant complications, comprises the essence of outpatient management in kidney transplant recipients (KTRs). However, the patient’s perspective is not always included in this process. Patients’ perspectives on their health after kidney transplantation, albeit subjective, are increasingly acknowledged as valuable healthcare outcomes and should be considered in order to provide patient-centred healthcare. Such outcomes are known as patient-reported outcomes (PROs; e.g. health-related quality of life and symptom burden) and are captured using PRO measures (PROMs). So far, PROMs have not been routinely used in clinical care for KTRs. In this review we will introduce PROMs and their potential application and value in the field of kidney transplantation, describe commonly used PROMs in KTRs and discuss structural PROMs implementation into kidney transplantation care.

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